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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor
(180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily
maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily
maintenance dose for the remainder of the study) for the prevention of major vascular events
(composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic
stroke or transient ischaemic attack (TIA).

[SOCRATES –Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES]

ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.

ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

Research Site

A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischaemic Stroke or TIA.

Age Continuous

Age, Customized

Gender, Male/Female

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

The population was the full analysis set, which included all randomized patients.

Number of Participants with Composite of Stroke/MI/Death

Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Number of Participants with Ischaemic Stroke

Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Net Clinical Outcome

Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Number of Participants with Composite of Ischaemic Stroke, MI and CV Death

Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).

Number of Participants with All-Cause Death

Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Number of Participants with CV Death

Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

Number of Participants with MI

Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.
Modified Rankin Score:
0 - No symptoms.
1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3 - Moderate disability. Requires some help, but able to walk unassisted.
4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6 - Dead.

Disability defined as mRS > 1.

Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at
baseline as explanatory variables.

The population was the full analysis set which included all randomized patients.

Number of participants by Severity of Stroke and Overall Disability

Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

Number of Participants with Stroke

Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Number of Participants with Fatal Stroke

Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Number of Participants with Disabling Stroke

<=-5

Missing

Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):

0	   No stroke symptoms
1-4	   Minor stroke
5-15    Moderate stroke
16-20  Moderate to severe stroke
21-42  Severe stroke.

NIHSS in patients with an index stroke event

Change in NIHSS

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each
dimension responders are asked to state their status on a three level ordinal scale; whether they
experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index
(health state utility) by applying scores from the EQ-5D value sets elicited from general
population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Include only results from patients who visit the site in-person.

EQ-5D at Visit 1 (Enrolment)

EQ-5D at Visit 2 (Day 7+-2d)

EQ-5D index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each
dimension responders are asked to state their status on a three level ordinal scale; whether they
experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index
(health state utility) by applying scores from the EQ-5D value sets elicited from general
population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

EQ-5D (EuroQol five dimensions questionnaire) at End of Treatment Visit

Include only results from patients who visit the site in-person. The Premature Treatment Discontinuation visit (PTDV) is only done for patients who prematurely and permanently stop study medication.

EQ-5D (EuroQol five dimensions questionnaire) at Premature Treatment Discontinuation Visit

Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

PLATO Major bleeding is defined as a bleed that is any one of:

- Fatal
- Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)
- Intrapericardial bleed with cardiac tamponade
- Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery
- Significantly disabling (eg. intraocular with permanent vision loss)
- Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)
- Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.

The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.

Number of Participants with PLATO Major Bleeding Event

Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Number of Participants with Premature Discontinuation of Study Drug due to Any Bleeding Adverse Event

Overall Study

Enrolled patients randomised to study drug: 99.2%; n=13199
Patients who were not randomised: 0.8%; n=108
Patients with eligibility criteria not fulfilled: 0.7%; n=93
Patient decision: 0.1%; n=15

Arms	Assigned Interventions
Experimental: ticagrelor	Drug: ticagrelor ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.
Active Comparator: Acetylsalicylic acid (ASA)	Drug: Acetylsalicylic acid (ASA) ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

[SOCRATES –Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES] - SOCRATES

Official Title

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